BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON FOCAL ABLATION SYSTEM

    MDR report key: 5971873 · Received September 22, 2016

    Report

    Report Number
    3008780134-2016-00012
    Event Type
    Injury
    Date Received
    September 22, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 21, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PERFORMED AS INTENDED. THE CONTROLLER WAS ANALYZED, AND NO ISSUE WAS FOUND. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR EFFECTS OF THE PRIOR ABLATION PERFORMED WITH THE C2 CRYOBALLOON DEVICE IN (B)(6) 2016.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PHYSICIAN REPORTED A TRAVERSABLE STRICTURE IN A PATIENT FOLLOW-UP. THE PATIENT REPORTED DYSPHAGIA AND WEIGHT LOSS OF 4 LBS. THE PATIENT RECEIVED ONE PRIOR CRYOBALLOON TREATMENT ON (B)(6) 2016. THE PHYSICIAN DID NOT DETERMINE IF THE STRICTURE WAS CAUSED BY PRIOR GERD OR EE (GASTROESOPHAGEAL REFLUX DISEASE AND EOSINOPHILIC ESOPHAGITIS) OR POSSIBLY DUE TO PREVIOUS CRYOABLATION TREATMENT. THE STRICTURE WAS DILATED, AND THE PATIENT RECEIVED ONE 10-SECOND ABLATION USING THE C2 CRYOBALLOON IN AN AREA APPROXIMATELY 5 CM FROM THE DILATION SITE. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621667 C2 CRYOBALLOON FOCAL ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS, INC. FG1012, FG1009 07082016-03, UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention