BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 7051278 · Received November 21, 2017

    Report

    Report Number
    3008780134-2017-00020
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    November 3, 2017
    Report Date
    November 3, 2017
    Manufacturer
    C2 THERAPEUTICS INC.
    Product Code
    GEH
    UDI-DI
    00854924006125
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATA WAS DOWNLOADED FROM THE CONTROLLER AND REVIEWED. ONE ERROR FOR LOW BALLOON PRESSURE WAS OBSERVED TOWARDS THE END OF THE PROCEDURE, PERHAPS DUE TO LOW CARTRIDGE REFRIGERANT. HOWEVER, NO ERRORS LEADING TO ANY INDICATION OF PERFORATIONS WERE IDENTIFIED. SEVEN (7) COMPLETE ABLATIONS WERE PERFORMED, ALL AT NORMAL OPERATING PRESSURES. THE DEVICE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    C2 THERAPEUTICS BECAME AWARE OF A SERIOUS ADVERSE EVENT ON (B)(6) 2017. - PATIENT HAS A HISTORY OF PRIMARY LUNG CANCER WITH AGGRESSIVE CHEMO RADIATION TREATMENT. - SUCCESSFUL CRYOBALLOON TREATMENT FOR SQUAMOUS CELL CARCINOMA IN (B)(6) 2017. - ON (B)(6) 2017 AN EMR WAS DONE TO REMOVE RESIDUAL SQUAMOUS CA. - ON (B)(6) 2017 SQUAMOUS CA WAS TREATED WITH CRYOBALLOON FOR RESIDUAL CA. CRYOBALLOON PRODUCT PERFORMED AS REQUIRED. - PERFORATION WAS NOTICED IN THE DISTAL ESOPHAGUS UPON REMOVAL OF THE CRYOBALLOON FROM THE SCOPE. - ON (B)(6) 2017 AT 3:30 PM THE PATIENT WAS DOING FINE. X-RAYS WERE NEGATIVE FOR FREE AIR. BARIUM SWALLOW TEST WILL BE PERFORMED TO EVALUATE STENT EFFECTIVENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828574 CRYOBALLOON ABLATION SYSTEM CYROSURIGICAL UNIT WITH ACCESSORIES GEH C2 THERAPEUTICS INC. FG 1012 / FG 1009 10252017-03 / 07262017-03 00854924006125

    Patients

    Seq Age Sex Outcome Treatment
    1