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C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, C...

FDA Device Recall #Z-1477-2017 — Class II — January 6, 2017

Recall Summary

Recall Number Z-1477-2017
Classification Class II — Moderate risk
Date Initiated January 6, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm C2 Therapeutics, Inc.
Location Redwood City, CA
Product Type Devices
Quantity 755 controller caps

Product Description

C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

Reason for Recall

The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Germany, Belgium, The Netherlands United Kingdom and China.

Lot / Code Information

All lots distributed between June 23, 2016 and December 20, 2016: UPDATE - expanded to include product distributed from February 1 2016 through February 8, 2017. All numbers below have been updated. Lot numbers: Expiry dates 01122016-02 12-Jul-16; 06242016-01 1-Jan-2017; 11282016-03 2-Jun-2017; 01042016-03 14-Jul-16; 06292016-02 6-Jan-2017; 09202016-01 21-Mar-2017; 07062016-01 8-Jan-2017; 09222016-01 23-Mar-2017; 01252016-02 02-Aug-16; 07082016-02 13-Jan 2017; 09232016-01 28-Mar-2017; 01282016-01 01-Aug-16; 07082016-03 14-Jan-2017; 09232016-02 27-Mar-2017; 01292016-01 02-Aug-16; 07152016-01 21-Jan-2017; 09292016-01 4-Apr-2017; 02022016-03 09-Aug-16; 07152016-02 20-Jan-2017; 09302016-03 4-Apr-2017; 02082016-01 09-Aug-16; 07212016-01 25-Jan-2017; 10052016-02 19-Apr-2017; 02092016-02 11-Aug-16; 07252016-01 28-Jan-2017; 10142016-01 18-Apr-2017; 02112016-02 17-Aug-16; 07262016-01 9-Feb-2017; 10192016-01 24-Apr-2017; 02172016-02 25-Aug-16; 07282016-02 2-Feb-2017; 10212016-01 25-Apr-2017; 02222016-01 26-Aug-16; 08022016-01 17-Feb-2017; 10242016-01 26-Apr-2017; 03012016-01 04-Sep-16; 08032016-02 5-Feb-2017; 10262016-02 1-May-2017; 03072016-01 10-Sep-16; 08112016-01 16-Feb-2017; 10282016-02 8-May-2017; 03102016-02 15-Sep-16; 08232016-01 26-Feb-2017; 11022016-01 9-May-2017; 03152016-03 21-Sep-16; 08262016-01 2-Mar-2017; 11042016-01 10-May-2017; 03282016-02 29-Sep-16; 09022016-01 8-Mar-2017; 11092016-01 15-May-2017; 03292016-01 31-Sep-16; 09092016-01 14-Mar-2017; 11142016-02 16-May-2017; 09122016-02; 15-Mar-2017; 11152016-02 18-May-2017; 04012016-01 06-Oct-16; 09192016-01 19-Mar-2017; 11162016-01 21-May-2017; 09192016-02 21-Mar-2017; 11282016-02 30-May-2017; 04062016-01 12-Oct-16; 11302016-02 02-Jun-17; 12052016-01 08-Jun-17; 04112016-04 14-Oct-16; 12052016-03 06-Jun-17; 04142016-01 20-Oct-16; 12072016-01 09-Jun-17; 04202016-02 21-Oct-16; 12092016-01 13-Jun-17; 05022016-02 05-Nov-16; 12132016-01 19-Jun-17; 05092016-01 11-Nov-16; 12152016-02 20-Jun-17; 05162016-02 18-Nov-16; 01042017-01 04-Jul-17; 05232016-01 25-Nov-16; 01052017-03 19-Jul-17; 05272016-01 02-Dec-16; 01052017-04 19-Jul-17; 06022016-02 09-Dec-16; 01092017-01 12-Jul-17; 06102016-01 14-Dec-16; 01102017-01 18-Jul-17; 06152016-01 21-Dec-16; 01132017-01 18-Jul-17; 06172016-01 23-Dec-16; 01132017-03 17-Jul-17; 07282016-02 02-Feb-17.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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