BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6762287 · Received August 2, 2017

    Report

    Report Number
    3008780134-2017-00010
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    April 21, 2017
    Report Date
    July 17, 2017
    Manufacturer
    C2 THERAPEUTICS INC
    Product Code
    GEH
    PMA / PMN Number
    K161202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT WAS PROBABLY RELATED TO THE PATIENT TAKING NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AS THESE DRUGS CAN INCREASE THE RISK OF STOMACH AND INTESTINAL ADVERSE REACTIONS SUCH AS BLEEDING OR ULCERS.

    Description of Event or Problem · 1

    PATIENT ORIGINALLY UNDERWENT CRYOABLATION PROCEDURE WITH THE C2 CRYOBALLOON ABLATION SYSTEM ON (B)(6) 2017. APPROXIMATELY 2 WEEKS AFTER THE PROCEDURE THE PATIENT REPORTED EXPERIENCING SYNCOPE (FAINTING) WHILE ABROAD IN (B)(6) AND WAS AIRLIFTED TO (B)(6). THE PATIENT PRESENTED WITH MELENA (DARK, STICKY FECES CONTAINING PARTIALLY DIGESTED BLOOD) BUT WAS NOT TRANSFUSED. THIS EVENT WAS NOT REPORTED TO C2 THERAPEUTICS. THE PATIENT REPORTED THAT DURING THIS PERIOD HE WAS ON NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND WAS NOT COMPLIANT WITH HIS PROTON-PUMP INHIBITOR (PPI). THE PHYSICIAN STATED THAT IT WAS UNCLEAR IF THE CRYOABLATION SITE BLED OR OF IT WAS A PEPTIC ULCER THAT BLED AND THAT NO BLEEDING WAS SEEN WHEN THE PATIENT WAS RE-SCOPED IN (B)(6). THE PHYSICIAN STRESSED THAT THE NSAIDS MAY HAVE EXACERBATED THE BLEEDING. THE PATIENT UNDERWENT A SECOND CRYOABLATION PROCEDURE USING THE C2 CRYOBALLOON ABLATION SYSTEM ON (B)(6) 2017 FOR 3, 10-SECOND ABLATIONS. THE PATIENT APPEARED TO HAVE SOME NARROWING OF THE ESOPHAGUS OR POSSIBLE STRICTURE, BUT DID NOT REPORT ANY DIFFICULTY SWALLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540722 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT WITH ACCESSORIES, PRODUCT CODE: GEH GEH C2 THERAPEUTICS INC FG 1012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other