BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C2 CRYOBALLOON ABLATION SYSTEM

    MDR report key: 6087953 · Received November 8, 2016

    Report

    Report Number
    3008780134-2016-00017
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 8, 2016
    Manufacturer
    C2 THERAPEUTICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K131523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE DEVICE DATA LOGS WERE REVIEWED, AND NO ANOMALIES WERE IDENTIFIED. THE DEVICE PERFORMED PER SPECIFICATION.

    Description of Event or Problem · 1

    (B)(6) PATIENT #2 - AFTER TREATMENT FOR SQUAMOUS DYSPLASIA, THREE PATIENTS REPORTED A FEVER (38.5 AND 39.2 DEGREES CELSIUS) AND CHEST PAIN. THIS INCREASE IN TEMPERATURE IS ALSO SEEN AFTER ESD AND RFA. THE HOSPITAL PERFORMED A CT SCAN AND DETERMINED THAT THE PATIENTS HAD PLEURAL EFFUSION AND NO OTHER ABNORMALITIES. PATIENTS DID NOT FEEL ILL AND DID NOT SUFFER FROM DYSPNEA. INDOMETHACIN WAS ADMINISTERED, AND THE TEMPERATURE DECREASED TO NORMAL. ASPIRIN WAS ALSO PRESCRIBED. AFTER FIVE DAYS, THE PATIENT LEFT HOSPITAL SAFELY WITHOUT ANY DISCOMFORT. THIS CASE WAS DISCUSSED WITH IRB, WHO DETERMINED THAT THIS EVENT WAS NOT A SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736525 C2 CRYOBALLOON ABLATION SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH C2 THERAPEUTICS, INC. FG1012, FG1009

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R