BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYO SPRAY ABLATION

    MDR report key: 2151601 · Received June 29, 2011

    Report

    Report Number
    3004534508-2011-00004
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE (IFU) AND TREATED WITHIN THE CLEARED INDICATIONS OF THE DEVICE. THE IFU CONTRAINDICATES THE USE OF CRYOTHERAPY WHERE AN ULCERATION OR MUCOSAL BREAK IS EVIDENT. PHYSICIAN DID NOT NOTE ANY ULCERATIONS OR MUCOSAL BREAKS PRIOR TO APPLICATION OF THE CRYOSPRAY TREATMENT. HE BELIEVES THE CATHETER MAY HAVE MOMENTARILY BEEN FROZEN TO THE MUCOSA AND THEN DISLODGED, ALLOWING ENTRY OF THE GAS INTO THE SUBMUCOSA.

    Description of Event or Problem · 1

    PT PRESENTED TO OUTPATIENT ENDOSCOPY (EGD) FOR CRYOSPRAY TREATMENT OF LOCALLY INVASIVE ESOPHAGEAL CANCER. A CRYOGEN DECOMPRESSION TUBE (CDT) WAS PLACED PRIOR TO CRYOSPRAY TREATMENT ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). TWO CYCLES OF 20 SECOND CRYOSPRAY WERE RENDERED WITHOUT DISTENTION. UPON APPLICATION OF A THIRD CYCLE, THE ABDOMINAL MONITORING NURSE NOTED DISTENTION AND CRYOSPRAY WAS STOPPED. SHORTLY AFTER, THE PT HAD A VISIBLE PRESENCE OF NITROGEN GAS IN HIS SUBCUTANEOUS TISSUE, INCLUDING HIS HEAD, NECK AND EYES. HE WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PT WAS DISCHARGED HOME ON THE FOURTH DAY WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO SPRAY ABLATION CRYO SPRAY ABLATION GEH CSA MEDICAL CC2-NAM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R